Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Next Science TM | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NXTSC | Active Comparator | This group will receive the NXTSC gel only. The NXTSC wound gel and its active agents are applied on the wound bed. A synthetic microfiber dressing will be applied to the surface of the wound. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site. ( NXTSC). |
|
| NXTSC plus SOC | Active Comparator | This group will receive the NXTSC wound gel plus Standard of Care. The NXTSC wound gel is applied to the wound bed. Local wound management will consist of diagnosing the wound biofilm and providing specific measures to suppress the wound biofilm to allow host healing. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds when this gel is used in conjunction with the current standard of care infection controls to treat microbial infection at the wound site.( Next Science Wound Gel, plus standard of care). |
|
| SOC | Active Comparator | This group will receive Standard of Care only. The Standard of Care is based on wound management intervention to remove wound slough by frequent debridement. Moist interactive wound care with multiple strategies to suppress biofilm is instituted. Determine the effect on wound treatment outcomes using standard of care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXTSC wound gel | Device | Subjects will receive NXTSC wound gel only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care | Percentage after 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randall D Wolcott, M.D. | Southwest Regional Wound Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NXTSC | This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only. |
| FG001 | NXTSC Plus SOC | This group will receive the NXTSC wound gel plus Standard of Care. NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only. |
| FG002 | Standard of Care | This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NXTSC | This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only. |
| BG001 | NXTSC Plus SOC | This group will receive the NXTSC wound gel plus Standard of Care. NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care | Posted | Number | percentage of participants | Percentage after 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NXTSC | This group will receive the NXTSC gel only. NXTSC wound gel: Subjects will receive NXTSC wound gel only. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall Wolcott | Southwest Regional Wound Care Center | 806-793-8869 | randy@randallwolcott.com |
Not provided
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NXTSC wound gel plus Standard of Care | Device | Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only. |
|
|
| Standard of Care Group | Device | Subjects will receive Standard of Care only. |
|
|
| BG002 | Standard of Care | This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standard of Care |
This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only. |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | NXTSC Plus SOC | This group will receive the NXTSC wound gel plus Standard of Care. NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only. | 0 | 15 | 0 | 15 |
| EG002 | Standard of Care | This group will receive Standard of Care only. Standard of Care Group: Subjects will receive Standard of Care only. | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided